In 2016 Rituxan had over $4 billion in sales in the United States, making it a lucrative area for the development of biosimilars. As of the publication of this article, Rituxan has two biosimilars awaiting FDA review in 2018 and one product in study (see Executive Summary Table below). All the biosimilars currently being developed have focused their studies on RA and NHL, which represents the primary usage of rituximab in practice and the more highly prevalent conditions for which Rituxan is approved.

Based on the available data it can be assumed that the FDA will approve the biosimilars for use with RA and NHL, but not for CLL and WG. Both Truxima® and Rixathon® have interchangeability data with Rituxan specifically within the treatment for rheumatoid arthritis. It is unknown whether this data is part of the FDA submission for these products in 2018, but if they are in the review, it can be expected that these products may be one of the first products to be listed as interchangeable. Since these are one of the first products that could be potentially reviewed for interchangeability it will be of interest to see if the FDA will generalize this to the drug or just within the RA indication.

For our complete review of the rituximab biosimilar pipeline, please go to the RJ Health website and register to receive the full publication. For an overview of the biosimilars development and approval process please see our whitepaper on Insights into the U.S. Biosimilar Marketplace Insights into the U.S. Biosimilar Marketplace. Finally, if you found this information helpful, please like and comment.

Executive Summary of Evaluation for Rituximab Pipeline:

Rituxan®
(Genentech)

Truxima®
(Celltrion/Teva)

Rituximab Biosimilar
(Amgen/Allergan)

Rixathon®
(Sandoz/Novartis)

Regulatory

Status

Marketed

Submitted for Approval

Not Submitted

Submitted for Approval

PDUFA

04/30/2018

07/12/2018

Indications

Non-Hodgkins Lymphoma (NHL)

Approved

Submitted for Approval

In Study

Submitted for Approval

Rheumatoid Arthritis (RA)

Approved

Submitted for Approval

In Study

Submitted for Approval

Chronic Lymphocytic Leukemia (CLL)

Approved

Wegner’s Granulomatosis

Approved

Interchangeable

Non-Hodgkins Lymphoma (NHL)

Rheumatoid Arthritis (RA)

Has supporting data

Has supporting data

Chronic Lymphocytic Leukemia (CLL)

Wegner’s Granulomatosis

Efficacy

Non-Hodgkins Lymphoma (NHL)

Similar to Rituxan

No Results

Similar to Rituxan

Rheumatoid Arthritis (RA)

Similar to Rituxan

No Results

Similar to Rituxan

Chronic Lymphocytic Leukemia (CLL)

Not Studied

Not Studied

Not Studied

Wegner’s Granulomatosis

Not Studied

Not Studied

Not Studied

Forecasted Sales
(in millions)Source: Pharma Intelligence Center

2018

$3,716

No Forecast

$145

$16

Pipeline Update:

April 5, 2018 – Celltrion announced the FDA issued a complete response letter (CRL) for their rituximabbiosimilar requesting additional information. While these actions may delay the FDA approval date, the manufacturer still anticipates approval in 2018.

Todd Cooperman

Todd Cooperman joined RJ Health in June 2016 as Vice President, Clinical Analytics. As Senior Vice President, Todd and his team work with our various clients to identify opportunities and solutions that result in improved medical drug spend and clinical management.